Meeting Annual U.S. FDA cGMP Training Requirements 2015

Topics

• Avoid complacency from past "good" FDA / ISO compliance
• Focus on key cGMP issues
• The major 21 CFR issues in 111, 210 / 211, and 820
• Developing the Annual Lesson Plan(s)
• How to address known problem areas during cGMP training
• Defect recognition
• Monitor and maintain `the edge`
• Stop unauthorized changes -- Prove `in control`

Who should Attend

• QA
• Senior management in Drugs, Devices, Biologics, Dietary Supplements
• R&D
• RA
• Production
• Engineering
• Consultants; others tasked with project leadership responsibilities
• Operations